Stephen T. Sinatra, M.D., F.A.C.C., F.A.C.N., C.N.S., C.B.T., is a board-certified cardiologist, certified bioenergetic psychotherapist, and certified nutrition and anti-aging specialist. He has lectured and facilitated workshops worldwide and has authored several publications and medical periodicals. He has been a featured guest on many national radio and television shows including CNN, MSNBC, Fox on Health, the Dr. Oz, The Doctors, and 700 Club shows, and The Today Show.

Dr. Burzynski Under Attack

Medical maverick, Stanislaw Burzynski, MD, PhD, who has helped cure terminal cancer patients with a non-toxic gene-targeted cancer therapy he developed, is, yet again, under attack. After a decade-long attempt to revoke the cancer pioneer’s medical license, which resulted in a Texas Supreme Court victory for Burzynski in 1996, the Texas Medical Board will again take Burzynski to trial on April 11, 2012. If the Board succeeds, the Burzynski clinic will likely be shut down, patients will suffer and the possibility of FDA-approval for Burzynski’s revolutionary cancer therapy, called antineoplaston treatment, will be lost.

Through the link above, you can also download, personalize and send (via email, fax or regular mail) letters opposing the upcoming prosecution to the Texas Legislative Oversight Committees and Texas Governor and 2012 Presidential candidate Rick Perry. Alliance for Natural Health (ANH-USA) has also provided a letter you can personalize and email to the to protest the Board’s actions.

Gov. Perry has recently been scrutinized in the press for his ties to pharmaceutical companies like Merck. While not directly accusing Dr. Burzynski of any offenses, Gov. Perry appointed many members (including heads) of the Texas Medical Board, as well as the Texas legislature committees which oversee the Board. After trying to take away the doctor’s medical license in the 1980s by accusing him of breaking a nonexistent law, the Texas Medical Board is now charging Burzynski with the off-label use of FDA drugs.

Burzynski, The Movie

Nominated for Best Documentary of 2011, Burzynski the Movie – Cancer is Serious Business explores the agonizing, yet victorious, 14-year journey Burzynski and his patients had to take in order to get FDA-approval for clinical trials of antineoplastons.

Antineoplastons and Cancer

Burzynski first discovered antineoplastons, which are peptides and amino acid derivatives that are native to the human body (they are found in blood and urine, but reproduced synthetically for medicinal use), in 1967. He identified that these peptides could control cancer growth, as well as that cancer patients are usually deficient in these peptides, as compared with healthy people.

Antineoplastons are gene-targeted therapeutic agents which activate genes that suppress tumor development and deactivate genes that encourage cancer. Essentially, antineoplastons “reprogram” cancer cells to act like normal cells and die off. Like the many conventional cancer drugs and treatments currently available, antineoplastons cannot promise a cure for all patients; they tend to more effective against brain cancer and lymphoma, and less effective against lung and breast cancers, and most end-stage cancers.

Unlike chemotherapy and radiation, however, which kill all localized cells – cancerous and healthy – antineoplastons only target cancer cells, and do not harm healthy cells. Hence, they stand to become a mainstream non-toxic alternative in the treatment of some cancers if FDA approved.

FDA Approval of Antineoplastons

Getting antineoplaston therapy approved by the FDA has been an excruciating process so far. While pharmaceutical companies are generally able to get their cancer drugs market-ready within a few months, Dr. Burzynski has fought for decades to get the FDA to sanction his antineoplaston treatment, and against the most ruthless of opposition.

Between 1985 and 1995, the FDA convened five grand jury investigations to indict Burzynski, which, if successful, would have resulted in the closure of his clinic and his going to prison. After four grand juries found the doctor innocent, the FDA finally succeeded in indicting Burzynski on attempt number five. However, after two trials, Burzynski was again found not at fault by the juries. Could Burzynski truly be so savvy that he can fool everyone but the FDA?

Burzynski’s patients, whose survival depended on continued antineoplaston treatment, testified on their doctor’s behalf throughout the prosecutions. Pressure from Congress and the public eventually forced the FDA to allow Burzynski to continue conducting clinical trials with antineoplastons despite a pending indictment. In 2004, the FDA explicitly acknowledged the potential of antineoplaston treatment as a cancer therapy in 2004 when it granted Orphan Drug status to two types of antineoplastons.1

As this point, Burzynski’s antineoplaston treatment for recurrent brain stem glioma (which affects children in 80 percent of cases) has completed phase II of the clinical trial process. Now the FDA has thrown another heartwrenching cog into the approval machine by mandating that patients who participate in the phase III trials must also receive radiation treatments together with antineoplaston treatments. Documentary film director Eric Mercola reports that the FDA justified this requirement by stating, “It would be unethical not to give radiation treatment to these patients.”

To elucidate the mind-boggling nature of the FDA’s radiation mandate, Mercola states:

“Most of the patients to be placed in these trials suffer from inoperable brain cancer. It has been firmly established, based on sound scientific evidence, that radiation treatment administered to the head can not only promote the growth of cancer, but it can result in “brain necrosis,” often killing the patient within one or two years after treatment… No hospital in the USA is allowing these Phase 3 antineoplaston “randomized” trials to be conducted, because they know they will never accrue a single patient due to [forced] radiation…What parent would put their child through that? Would you? The FDA does not at all care that the [antineoplaston] therapy has cured an upward of 30 percent of patients treated of this disease without the inclusion of radiation…[the agency knows] radiation is not necessary to cure any of these kids while using antineoplastons.”

The National Cancer Institute at the National Institutes of Health (NIH) even states on various web pages2:

“Conventional treatment for children with diffuse intrinsic pontine glioma (DIPG) is radiation therapy to involved areas. Such treatment will result in transient benefit for most patients, but over 90 percent of patients will die within 18 months of diagnosis…. Currently, no chemotherapeutic strategy…when added to radiation therapy has led to long-term survival for children with DIPG.”

“Given the dismal prognosis for patients with diffuse intrinsic pontine glioma…Patients should be considered for entry into trials of novel therapeutic approaches because there are no standard agents that have demonstrated a clinically significant activity.”

In other words, radiation and chemotherapy have, so far, proved ineffective to treat patients with brain gliomas who could potentially participate in Burzynski’s phase III trials. How, then, could it possibly be unethical to not treat patients with radiation, an agent that ultimately leads to death in 90 percent of cases?

In Burzynski’s 2003 and 2006 phase II studies, where radiation was not employed, survival 2 years after treatment with antineoplastons (not cancer diagnosis) was 33.3 and 39 percent, respectively; survival 5 years after treatment was, respectively, 17 and 22 percent. Clearly, antineoplaston treatment has shown promise to be more effective against brain stem glioma than radiation, yet the FDA is forcing all Burzynski’s phase III trial participants to receive radiation treatments which generally cause more damage than good. Essentially, the FDA is not even giving Burzynski’s patients a fighting chance against their cancers, and is not allowing Burzynski the opportunity to demonstrate just how much more effective antineoplastons may be against cancer than “standard agents.”

Connecting the Dots

Without exploring possible ulterior motives the FDA might have for trying to prevent public access to a potential lifesaving and non-toxic cancer therapy, looking at the following bits of information may shine light on the situation at hand:

Cancer treatment is big business. The NIH estimates that the direct medical costs of cancer surpassed $100 billion in 2010.3

Chemotherapy, radiation and surgery are the “standard” cancer treatments; chemotherapy and radiation are usually employed when cancer is inoperable.

Pharmaceutical companies and oncologists derive obscene profits from chemotherapy agents and drugs prescribed to counteract their side effects. The system through which oncologists purchase cancer treatments from pharmaceutical companies, then bill insurance companies and Medicare at much higher rates, is said to encourage the overuse of chemotherapy and other expensive drugs, and to override any incentive to find better treatments or a cancer cure.4

In 2007, a federal judge in Boston ordered AstraZeneca and Bristol-Myers Squibb to pay almost $14 million in damages for overcharging on cancer drugs (legal analysts have called it a test case for a nationwide class action suit involving Amgen, Abbot Labs and ten other drug companies).5

Approval of Burzynski’s antineoplaston treatment would represent a change in the big-pharma status quo, as a biochemist physician and his small biopharmaceutical company would hold exclusive patent and distribution rights on a paradigm-shifting cancer breakthrough treatment. If a physician and scientist were to own rights to a non-toxic alternative treatment, major pharmaceutical companies would stand to lose serious profits.

In 1982, FDA Bureau of Drugs Director Richard Crout was quoted as saying, “I never have and never will approve a new drug to an individual, but only to a large pharmaceutical firm with unlimited finances.”6

The FDA has been accused before of protecting cancer drug profits. In the May 14, 2007 Wall Street Journal, Mark Thorton, MD, PhD, a former FDA official in the Office of Oncology Products, denounced the FDA’s refusal to approve Provenge, a new immunotherapy vaccine for prostate cancer, citing that “the FDA succeeded in killing not one but two safe, promising therapies designed and developed to act by stimulating a patient’s immune system against cancer.”7

Commenting on Thorton’s statements, journalist Evelyn Pringle wrote:

“New therapies pose a grave threat to the cancer industry as a whole, and the lost profits would not be limited to the sale of products. The pharmaceutical giants have spent a small fortune to gain control of every segment of the industry, from researchers to government regulators…the profits up for grabs have become so enormous that critics say the goal of industry-controlled research is no longer focused on finding a cure for cancer to save lives. Instead, the focus is on thwarting the development and approval of new therapies in order to protect the profits of the treatments already on the market.”8

Congress has, in the past, found that FDA advisory committee members with financial ties to pharmaceutical companies (ownership of company stock or patent rights to certain treatments) have had such conflicts of interest waived during approval processes.9

Nine FDA scientists wrote this letter to a White House official, urging change at the “fundamentally broken” FDA with information about corruption and distortion in the scientific review process by FDA managers.

While the FDA is handicapping Burzynski by forcing all of his phase III clinical trial patients to undergo radiation treatment, it has given accelerated approval (i.e. mandated completion of phase II only) for a number of drugs manufactured by major pharmaceutical companies that are less effective against brain cancer than antineoplaston treatments.10

The FDA granted Orphan Drug designation to Antineoplastons A10 and AS2-1 for the treatment of brainstem glioma and has since extended this designation to all gliomas. The FDA’s orphan drug program serves to encourage research, development and approval of products for treatment of uncommon diseases.